NCT00167388

The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants

The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 25 Weeks – 38 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to see if a blood transfusion changes how fast blood flows to the intestines of a premature baby. Blood flow is measured by an ultrasound test. The investigators also look to see if the blood flow to the intestines depends on whether the baby feeds or doesn't feed during the blood transfusion.

Detailed description

Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether premature infants should be fed during a blood transfusion. The effects of a blood transfusion on superior mesenteric artery blood flow velocity and the post-prandial hyperemia are not known. We hypothesize that the post-prandial change in mesenteric blood flow velocity (BFV) will be the same before as after a packed red blood cell (PRBC) transfusion among anemic premature infants. Sixty anemic infants (25-32 weeks GA, feeding \>= 60 cc/kg/day) will undergo pre- and post-feed superior mesenteric artery Doppler studies both before and after a blood transfusion. Infants will be stratified by current weight into two groups (\< 1250 grams and \> 1250 grams). In each weight stratum the infants will be randomized to feeding or NPO during the PRBC transfusion. Randomization will be by block design, with block sizes ranging from two to six infants. The investigator performing the Doppler studies will remain masked to the feeding assignment of the infant. The primary outcome for the study is the superior mesenteric artery blood flow velocity response to feeding between anemic and non-anemic states among premature infants. Our secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in these infants. Statistical analysis will include paired and unpaired Student t-tests and regression analysis.

Conditions

• Anemia of Prematurity

Interventions

Type	Name	Description
OTHER	feed during blood transfusion	babies receiving the intervention are fed during the PRBC transfusion

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-09-14
• Last updated: 2017-07-21
• Results posted: 2017-07-21

Locations

1 site across 1 country: United States